2018 PRIOR AUTHORIZATION CRITERIA TABLE OF CONTENTS

Transcription

1 2018 PRIOR AUTHORIZATION CRITERIA TABLE OF CONTENTS ABSTRAL...86 ADASUVE...31 ADCIRCA...16 ADEMPAS...18 AFINITOR AFINITOR DISPERZ ALECENSA ALUNBRIG amabelz tablet AMITIZA...21 amitriptyline tablet AMOXAPINE AMPYRA...22 ANADROL ANDRODERM...29 ANDROGEL 1.62%...29 ANDROXY...28 APOKYN...33 ARANESP...81 ARCALYST...34 aripiprazole ODT...31 aripiprazole solution, tablet...31 ARISTADA...31 Updated 03/2018 IDEAL

2 armodafinil tablet...35 AVONEX AVONEX PEN AVONEX PREFILLED KIT AXIRON...29 BENLYSTA...38 benztropine tablet BETASERON bexarotene capsule BOSULIF buprenorphine sublingual tablet...69 buprenorphine-naloxone sublingual tablet...70 butalbital/acetaminophen mg tablet butalbital/acetaminophen/caffeine mg capsule butalbital/acetaminophen/caffeine mg capsule, tablet butalbital/aspirin/caffeine mg capsule CABOMETYX CALQUENCE CAPRELSA CHLORPROMAZINE injection...31 chlorpromazine tablet...31 chorionic gonadotropin injection...71 CINRYZE...93 clemastine tablet clomipramine capsule clonazepam ODT...40 Updated 03/2018 IDEAL

3 clonazepam tablet...40 clorazepate tablet...42 clozapine ODT 25 mg, 100 mg...31 clozapine tablet...31 COMETRIQ COPAXONE CORLANOR...72 COSENTYX...49 COSENTYX SENSOREADY PEN...49 COTELLIC CRESEMBA...73 cyclobenzaprine tablet DAKLINZA...74 danazol capsule...23 desipramine tablet DIAZEPAM 1 mg/ml oral solution...44 diazepam intensol concentrate...44 diazepam tablet...44 dicyclomine capsule, tablet digoxin 0.25 mg tablet DIVIGEL doxepin capsule doxepin oral concentrate EGRIFTA...76 ELIDEL...36 ENBREL...51 Updated 03/2018 IDEAL

4 ENBREL MINI...51 ENBREL SURECLICK...51 ENTRESTO...78 EPCLUSA...79 EPOGEN...83 ERGOLOID MESYLATES tablet ERIVEDGE ESBRIET estradiol patch, tablet estradiol/norethindrone tablet ESTROPIPATE FANAPT...31 FANAPT TITRATION PACK...31 FARYDAK fentanyl citrate oral lozenge...87 fentanyl transdermal patch FIRAZYR...95 FLUPHENAZINE concentrate, elixir, injection...31 fluphenazine decanoate 25 mg/ml injection...31 fluphenazine tablet...31 FORTEO...88 GAMMAGARD GAMMAGARD SD GAMMAPLEX GAMUNEX-C GATTEX...89 Updated 03/2018 IDEAL

5 GEODON injection...31 GILOTRIF glatiramer 20 mg/ml, 40 mg/ml injection glatopa GRASTEK H.P. ACTHAR GEL...14 HAEGARDA...97 haloperidol concentrate, tablet...31 haloperidol decanoate injection...31 haloperidol lactate injection...31 HARVONI...99 HETLIOZ HEXALEN HUMIRA...53 HUMIRA PEDIATRIC CROHNS DISEASE STARTER PACK...53 HUMIRA PEN...53 HUMIRA PEN-CROHNS DISEASE STARTER...53 HUMIRA PEN-PSORIASIS STARTER...53 hydroxyzine syrup, tablet IBRANCE ICLUSIG IDHIFA ILARIS imatinib mesylate tablet IMBRUVICA imipramine tablet Updated 03/2018 IDEAL

6 imiquimod 5% cream INLYTA INVEGA SUSTENNA...31 INVEGA TRINZA...31 IRESSA JAKAFI JUXTAPID KALYDECO KINERET...55 KISQALI KISQALI FEMARA THERAPY PACK KORLYM KUVAN KYNAMRO LATUDA...31 LAZANDA...85 LENVIMA LETAIRIS lidocaine 2% gel lidocaine 4% solution lidocaine 5% ointment lidocaine 5% transdermal patch lidocaine/prilocaine % cream linezolid suspension, tablet LINZESS LONSURF Updated 03/2018 IDEAL

7 lopreeza tablet lorazepam tablet...46 loxapine capsule...31 LYNPARZA MATULANE MAVYRET megestrol 40mg/mL suspension megestrol tablet MEKINIST memantine solution, tablet memantine titration pak MENEST methocarbamol 500 mg, 750 mg tablet methyltestosterone capsule...28 mimvey lo tablet mimvey tablet modafinil tablet morphine sulfate er tablet MYALEPT NATPARA NERLYNX NEXAVAR NINLARO nitrofurantoin 50 mg, 100 mg capsule nitrofurantoin suspension NORTHERA Updated 03/2018 IDEAL

8 nortriptyline capsule NORTRIPTYLINE solution NOXAFIL injection, suspension, tablet NUCYNTA ER NUPLAZID OCALIVA octreotide injection ODOMZO OFEV olanzapine injection, tablet...31 olanzapine ODT...31 OLYSIO OMNITROPE...90 ONFI...48 OPSUMIT ORALAIR ORENCIA...57 ORKAMBI OTEZLA oxandrolone tablet...24 OXYCONTIN paliperidone er 24hr tablet...31 paroxetine tablet PAXIL suspension PEGASYS PEGASYS PROCLICK Updated 03/2018 IDEAL

9 perphenazine tablet...31 PHENOBARBITAL 15 mg, 30 mg, 60 mg, 100 mg tablet phenobarbital 16.2 mg, 32.4 mg, 64.8 mg, 97.2 mg tablet phenobarbital elixir, solution PHENOBARBITAL injection PLEGRIDY PLEGRIDY PEN PLEGRIDY STARTER PACK POMALYST PRALUENT pregnyl...71 PREMARIN PREMPHASE PREMPRO PROCRIT...83 PROLASTIN-C...20 PROLIA PROMACTA promethazine suppository, syrup, tablet protriptyline tablet quetiapine er tablet...31 quetiapine tablet...31 RAGWITEK REGRANEX RELISTOR REMICADE...59 Updated 03/2018 IDEAL

10 REPATHA REPATHA PUSHTRONEX SYSTEM REPATHA SURECLICK RESTASIS REVLIMID REXULTI...31 RISPERDAL CONSTA...31 risperidone ODT...31 risperidone solution, tablet...31 RITUXAN...61 RITUXAN HYCELA...63 RUBRACA RYDAPT SAMSCA SAPHRIS...31 SENSIPAR SIGNIFOR SIGNIFOR LAR sildenafil tablet SIVEXTRO SOMATULINE DEPOT SOMAVERT SOVALDI SPRYCEL STELARA...65 STIVARGA Updated 03/2018 IDEAL

11 STRENSIQ SUBOXONE...70 SUTENT SYLATRON SYPRINE tacrolimus ointment...37 TAFINLAR TAGRISSO TARCEVA TASIGNA TECFIDERA TECFIDERA STARTER PACK TECHNIVIE TENCON testosterone 1% gel...29 testosterone 1% gel pump...29 testosterone 30 mg/actuation solution (generic for Axiron)...29 testosterone cypionate injection...26 testosterone enanthate injection...26 tetrabenazine tablet THALOMID thioridazine tablet...31 thiothixene capsule...31 TRACLEER...67 tramadol ER tablet tretinoin capsule Updated 03/2018 IDEAL

12 trientine capsule trifluoperazine tablet...31 trimipramine capsule TYKERB TYSABRI UPTRAVI VENCLEXTA VENCLEXTA STARTING PACK VENTAVIS VERSACLOZ...31 VERZENIO VIEKIRA PAK VIEKIRA XR voriconazole injection, suspension, tablet VOSEVI VOTRIENT VRAYLAR...31 XALKORI XOLAIR XTANDI XYREM zaleplon capsule ZAVESCA ZEJULA ZELBORAF ZEPATIER Updated 03/2018 IDEAL

13 ziprasidone capsule...31 ZOHYDRO ER ZOLINZA zolpidem tablet ZYDELIG ZYKADIA ZYPREXA RELPREVV...31 ZYTIGA Updated 03/2018 IDEAL

14 Prior Authorization Group Acthar HP Gel PA H.P. ACTHAR GEL All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for approval require BOTH of the following: 1. ONE of the following: a. Patient has a diagnosis of infantile spasm OR b. Patient has a diagnosis of nephrotic syndrome OR c. Patient has a diagnosis of relapsing multiple sclerosis AND ALL of the following: i. Patient is experiencing an acute exacerbation AND ii. If indicated, there is evidence of a claim that the patient is currently on a disease modifying drug (DMD) in the past 90 days (e.g. Aubagio, Avonex, Betaseron, Copaxone (glatiramer acetate), Extavia, Gilenya, Glatopa (glatiramer acetate), Lemtrada, Novantrone (mitoxantrone), Plegridy, Rebif, Tecfidera, Tysabri, or Zinbryta) to control disease progression OR has a documented intolerance, FDA labeled contraindication, or hypersensitivity to a DMD AND iii. Patient has failed corticosteroid therapy within the last 30 days or has an FDA labeled contraindication to corticosteroid therapy (e.g. methylprednisolone 1gm IV for 3-5 days) OR d. Patient has another FDA approved indication: Psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, severe erythema multiforme, Stevens-Johnson syndrome, systemic lupus erythematosus, systemic dermatomyositis (polymyositis), serum sickness, keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation and symptomatic sarcoidosis AND patient has failed corticosteroid therapy within the last 30 days or has an FDA labeled contraindication to corticosteroid therapy (e.g. methylprednisolone 1gm IV for 3-5 days) OR e. Patient has another indication that is supported in CMS approved compendia for the requested agent AND patient has failed corticosteroid therapy within the Updated 03/2018 IDEAL

15 last 30 days or has an FDA labeled contraindication to corticosteroid therapy (e.g. methylprednisolone 1gm IV for 3-5 days) AND 2. The dose is within the FDA labeled or CMS approved compendia dosing for the requested indication For diagnosis of infantile spasm, patient is less than 24 months of age. For diagnosis of nephrotic syndrome, patient is greater than 2 years of age. 6 months for infantile spasm, 1 month for all other indications Updated 03/2018 IDEAL

16 Prior Authorization Group Adcirca PA ADCIRCA All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent AND Concurrently taking an phosphodiesterase type 5 (PDE-5) inhibitor (e.g. Cialis, Viagra) with the requested agent Criteria for initial approval require ONE of the following: A. BOTH of the following: i. ONE of the following: a. There is evidence of a claim that the patient (pt) is currently being treated with the requested agent within the past 90 days OR b. Prescriber states pt is using the requested agent AND is at risk if therapy is changed AND ii. Pt has an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested agent OR B. Pt has a diagnosis of pulmonary arterial hypertension (PAH), WHO Group 1 as determined by right heart catheterization AND ALL of the following: i. Pt s World Health Organization (WHO) functional class is II or greater AND ii. Pt has a mean pulmonary arterial pressure greater than or equal to 25 mmhg AND iii. Pt has a pulmonary vascular resistance greater than 3 Wood units AND iv. ONE of the following: a. Requested agent will be utilized as monotherapy OR b. Requested agent is for use in combination with Letairis (ambrisentan) for dual therapy ONLY OR c. Requested agent will be utilized for add-on therapy to existing monotherapy (dual therapy: except for dual therapy requests for Adcirca with Letairis), then BOTH of the following: 1. Pt has unacceptable or deteriorating clinical status despite established PAH pharmacotherapy AND 2. Requested agent is in a different therapeutic class OR d. Requested agent will be utilized for add-on therapy to existing dual therapy (triple therapy), then ALL of the following: Updated 03/2018 IDEAL

17 1. A prostanoid has been started as one of the agents in the triple therapy unless the pt has a documented intolerance, FDA labeled contraindication, or hypersensitivity to a prostanoid AND 2. Pt has unacceptable or deteriorating clinical status despite established PAH pharmacotherapy AND 3. All three agents in the triple therapy are from a different therapeutic class OR C. Pt has an indication that is supported in CMS approved compendia for the requested agent Approval will be for 12 months Criteria for renewal approval require ALL of the following: 1. Pt has been previously approved for the requested agent through the plan s PA criteria AND 2. Pt has an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested agent AND 3. Pt is responding to therapy with the requested agent Updated 03/2018 IDEAL

18 Prior Authorization Group Adempas PA ADEMPAS All FDA-approved indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for initial approval require BOTH of the following: 1. ONE of: A. BOTH of: i. ONE of: a. There is evidence of a claim that patient (pt) is currently being treated with the requested agent within the past 90 days OR b. Prescriber states the pt is using the requested agent AND is at risk if therapy is changed AND ii. Pt has an FDA labeled indication for the requested agent OR B. Pt has a diagnosis (dx) of CTEPH, WHO Group 4 as determined by ventilation-perfusion scan and a confirmatory selective pulmonary angiography AND ALL of: i. ONE of: a. Pt is NOT a candidate for surgery OR b. Pt has had pulmonary endarterectomy AND has persistent or recurrent disease AND ii. Pt has a mean pulmonary arterial pressure greater than or equal to 25 mmhg AND iii. Pt has a pulmonary capillary wedge pressure less than or equal to 15 mmhg OR C. Pt has a dx of PAH, WHO Group 1 as determined by right heart catheterization AND ALL of: i. Pt s WHO functional class is II or greater AND ii. Pt has a mean pulmonary arterial pressure greater than or equal to 25 mmhg AND iii. Pt has a pulmonary vascular resistance greater than 3 Wood units AND 2. ONE of: A. Requested agent will be utilized as monotherapy OR B. Requested agent will be utilized for add-on therapy to existing monotherapy (dual therapy), then BOTH of: Updated 03/2018 IDEAL

19 i. Pt has unacceptable or deteriorating clinical status despite established pharmacotherapy AND ii. Requested agent is in a different therapeutic class OR C. Requested agent will be utilized for add-on therapy to existing dual therapy (triple therapy), then ALL of: i. Prostanoid therapy has been started as one of the agents in the triple therapy unless the pt has a documented intolerance, FDA labeled contraindication, or hypersensitivity to a prostanoid AND ii. Pt has unacceptable or deteriorating clinical status despite established pharmacotherapy AND iii. All three agents in the triple therapy are from a different therapeutic class Approval will be for 12 months Criteria for renewal approval require ALL of the following: 1. Pt has been previously approved for the requested agent through the plan s PA criteria AND 2. Pt has an FDA labeled indication for the requested agent AND 3. Pt is responding to therapy with the requested agent Updated 03/2018 IDEAL

20 Prior Authorization Group Alpha-1-Proteinase Inhibitor PA - Prolastin-C PROLASTIN-C All FDA-approved indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for initial approval require ALL of the following: 1. Patient has a diagnosis of alpha-1 antitrypsin deficiency (A1AT) AND 2. Patient has a pre-treatment serum alpha-1 antitrypsin (A1AT) levels less than 11 µm/l (80 mg/dl by immunodifussion or 57 mg/dl using nephelometry) AND 3. Patient has a phenotype variant associated with A1AT (i.e. PiZZ, PiSZ, PiZ/Null or PiNull/Null) AND 4. Patient has emphysema with a documented baseline FEV1 of 65% or less of predicted AND 5. The dose requested is within the FDA labeled dose Criteria for renewal approval require ALL of the following: 1. Patient has been previously approved for the requested agent through the plan s PA criteria and is responding to therapy AND 2. Patient has a diagnosis of alpha-1 antitrypsin deficiency (A1AT) with clinically evident emphysema AND 3. The dose requested is within the FDA labeled dose Approval will be for 12 months Updated 03/2018 IDEAL

21 Prior Authorization Group Amitiza PA AMITIZA All FDA-approved indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for approval require BOTH of the following: 1. Patient has ONE of the following diagnoses: A. Chronic idiopathic constipation with documentation of symptoms for at least 3 months OR B. Irritable bowel syndrome with constipation with documentation of symptoms for at least 3 months AND the patient is female OR C. Opioid-induced constipation with chronic non-cancer pain AND BOTH of the following: i. Patient has chronic use of an opioid agent in the past 90 days AND ii. Patient is NOT receiving a diphenylheptane opioid (e.g. methadone) in the past 90 days AND 2. ONE of the following: A. Patient has tried at least one standard prescription laxative therapy for constipation lactulose or polyethylene glycol 3350 OR B. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to at least one standard prescription laxative therapy for constipation lactulose or polyethylene glycol 3350 Patient is 18 years of age or over Approval will be for 12 months Updated 03/2018 IDEAL

22 Prior Authorization Group Ampyra PA AMPYRA All FDA-approved indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for initial approval require BOTH of the following: 1. Patient has a diagnosis of multiple sclerosis (MS) AND 2. If the patient has relapsing form of MS, ONE of the following: A. There is evidence of a claim that the patient is receiving concurrent therapy within the past 30 days with a disease modifying agent (e.g. Aubagio, Avonex, Betaseron, Copaxone (glatiramer), Extavia, Gilenya, Glatopa (glatiramer), Lemtrada, mitoxantrone, Plegridy, Rebif, Tecfidera, or Tysabri) OR B. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to a disease modifying agent Criteria for renewal approval require ALL of the following: 1. Patient has been previously approved for the requested agent through the plan s PA criteria AND 2. Patient has a diagnosis of multiple sclerosis (MS) AND 3. Patient has demonstrated a stabilization or improvement from baseline in timed walking speed (timed 25 foot walk) Prescriber is a neurologist or the prescriber has consulted with a neurologist Initial approval 3 months.12 months for renewal. Updated 03/2018 IDEAL

23 Prior Authorization Group Anabolic Steroid PA - Danazol danazol capsule All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for approval require BOTH of the following: 1. Patient has ONE of the following diagnoses: a. Patient has an FDA labeled indication for the requested agent OR b. Patient has an indication that is supported in CMS approved compendia for the requested agent AND 2. ONE of the following: a. Patient is NOT currently treated with another androgen or anabolic steroid within the past 90 days OR b. The current androgen or anabolic steroid will be discontinued prior to starting the requested agent OR c. Prescriber has submitted documentation in support of therapy with more than one agent Approval will be for 12 months Updated 03/2018 IDEAL

24 Prior Authorization Group Anabolic Steroid PA - Oxandrolone oxandrolone tablet All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for approval require BOTH of the following: 1. Patient has ONE of the following diagnoses: a. Patient has AIDS/HIV-associated wasting syndrome (defined as unexplained involuntary weight loss greater than 10% baseline body weight with obvious wasting or body mass index less than 18.5 kg/m2) AND all other causes of weight loss have been ruled out OR b. Patient is a female child or adolescent with Turner syndrome AND is currently receiving growth hormone OR c. Patient has weight loss following extensive surgery, chronic infections, or severe trauma OR d. Patient has chronic pain from osteoporosis OR e. Patient is on long-term administration of oral or injectable corticosteroids AND 2. ONE of the following: a. Patient is NOT currently treated with another androgen or anabolic steroid within the past 90 days OR b. The current androgen or anabolic steroid will be discontinued prior to starting the requested agent OR c. Prescriber has submitted documentation in support of therapy with more than one agent Approval will be for 12 months Updated 03/2018 IDEAL

25 Prior Authorization Group Anabolic Steroid PA - Oxymetholone ANADROL-50 All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for approval require ALL of the following: 1. Patient has ONE of the following diagnoses: a. Patient has anemia caused by deficient red cell production, including acquired aplastic anemia, congenital aplastic anemia, myelofibrosis and the hypoplastic anemias due to the administration of myelotoxic drugs OR b. Patient has anemia associated with chronic renal failure AND ONE of the following: i. Patient s medication history indicates previous use of an erythropoiesisstimulating agent OR ii. Patient has a documented intolerance, FDA labeled contraindication or hypersensitivity to an erythropoiesis-stimulating agent AND 2. Patient has a hematocrit (Hct) value less than 30% AND 3. ONE of the following: a. Patient is NOT currently treated with another androgen or anabolic steroid within the past 90 days OR b. The current androgen or anabolic steroid will be discontinued prior to starting the requested agent OR c. Prescriber has submitted documentation in support of therapy with more than one agent Approval will be for 12 months Updated 03/2018 IDEAL

26 Prior Authorization Group Androgen Injectable PA testosterone cypionate injection testosterone enanthate injection All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for approval require ALL of the following: 1. Patient has ONE of the following diagnoses: a. Patient is a male with AIDS/HIV-associated wasting syndrome, defined as unexplained involuntary weight loss (greater than 10% baseline body weight) with obvious wasting OR body mass index less than 18.5 kg/m2 AND all other causes of weight loss have been ruled out OR b. Patient is a female with metastatic/inoperable breast cancer OR c. Patient is a male with primary or secondary (hypogonadotropic) hypogonadism OR d. Patient is an adolescent male with delayed puberty AND 2. Males only: Patient has a measured current or pretreatment total serum testosterone level that is below the testing laboratory s lower limit of the normal range or is less than 300 ng/dl OR a free serum testosterone level that is below the testing laboratory s lower limit of the normal range AND 3. ONE of the following: a. Patient is NOT currently treated with another androgen or anabolic steroid within the past 90 days OR b. The current androgen or anabolic steroid will be discontinued prior to starting the requested agent OR c. Prescriber has submitted documentation in support of therapy with more than one agent Approval will be 6 months for delayed puberty, 12 months for all other indications Updated 03/2018 IDEAL

27 Updated 03/2018 IDEAL

28 Prior Authorization Group Androgen Oral PA ANDROXY methyltestosterone capsule All FDA-approved indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for approval require ALL of the following: 1. Patient has ONE of the following diagnoses: a. Patient is a male with cryptorchidism OR b. Patient is a male with hypogonadism OR c. Patient is an adolescent male with delayed puberty OR d. Patient is a female with metastatic/inoperable breast cancer AND 2. Males only: Patient has a measured current or pretreatment total serum testosterone level that is below the testing laboratory s lower limit of the normal range or is less than 300 ng/dl OR a free serum testosterone level that is below the testing laboratory s lower limit of the normal range AND 3. ONE of the following: a. Patient is NOT currently treated with another androgen or anabolic steroid within the past 90 days OR b. The current androgen or anabolic steroid will be discontinued prior to starting the requested agent OR c. Prescriber has submitted documentation in support of therapy with more than one agent Approval will be 6 months for delayed puberty, 12 months for all other indications Updated 03/2018 IDEAL

29 Prior Authorization Group Androgen Topical PA ANDRODERM ANDROGEL 1.62% AXIRON testosterone 1% gel testosterone 1% gel pump testosterone 30 mg/actuation solution (generic for Axiron) All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for approval require ALL of the following: 1. Patient has ONE of the following diagnoses: a. Patient has AIDS/HIV-associated wasting syndrome, defined as unexplained involuntary weight loss (greater than 10% baseline body weight) with obvious wasting OR body mass index less than 18.5 kg/m2 AND all other causes of weight loss have been ruled out OR b. Patient is a male with primary or secondary (hypogonadotropic) hypogonadism AND 2. Males only: Patient has a measured current or pretreatment total serum testosterone level that is below the testing laboratory s lower limit of the normal range or is less than 300 ng/dl OR a free serum testosterone level that is below the testing laboratory s lower limit of the normal range AND 3. ONE of the following: a. Patient is NOT currently treated with another androgen or anabolic steroid within the past 90 days OR b. The current androgen or anabolic steroid will be discontinued prior to starting the requested agent OR c. Prescriber has submitted documentation in support of therapy with more than one agent Approval will be for 12 months Updated 03/2018 IDEAL

30 Updated 03/2018 IDEAL

31 Prior Authorization Group Antipsychotics PA ADASUVE aripiprazole ODT aripiprazole solution, tablet ARISTADA CHLORPROMAZINE injection chlorpromazine tablet clozapine tablet clozapine ODT 25 mg, 100 mg FANAPT FANAPT TITRATION PACK fluphenazine decanoate 25 mg/ml injection FLUPHENAZINE concentrate, elixir, injection fluphenazine tablet GEODON injection haloperidol decanoate injection haloperidol lactate injection haloperidol concentrate, tablet INVEGA SUSTENNA INVEGA TRINZA LATUDA loxapine capsule olanzapine injection, tablet olanzapine ODT paliperidone er 24hr tablet perphenazine tablet quetiapine tablet quetiapine er tablet REXULTI RISPERDAL CONSTA risperidone solution, tablet risperidone ODT SAPHRIS thioridazine tablet thiothixene capsule trifluoperazine tablet VERSACLOZ VRAYLAR ziprasidone capsule ZYPREXA RELPREVV All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Updated 03/2018 IDEAL

32 Program applies to new starts only. PA does NOT apply to patients less than 65 yrs of age. Criteria for approval require BOTH of the following: 1. Patient has an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested agent AND 2. ONE of the following: A. There is evidence of a claim that the patient is currently being treated with the requested agent within the past 180 days OR B. Prescriber states the patient is currently using the requested agent OR C. IF dementia-related psychosis, BOTH of the following: i. Dementia-related psychosis is determined to be severe or the associated agitation, combativeness, or violent behavior puts the patient or others in danger AND ii. Prescriber has documented that s/he has discussed the risk of increased mortality with the patient and/or the patient s surrogate decision maker Approval authorizations will apply to the requested medication only. Approval will be for 12 months Updated 03/2018 IDEAL

33 Prior Authorization Group Apokyn PA APOKYN All FDA-approved indications not otherwise excluded from Part D. Receiving a 5-HT3 antagonist (e.g., ondansetron, granisetron, dolasetron, palonosetron, alosetron) concomitantly with the requested agent Criteria for approval require BOTH of the following: 1. The requested agent will be used to treat acute, intermittent hypomobility, off episodes (muscle stiffness, slow movements, or difficulty starting movement) associated with advanced Parkinson s disease AND 2. There is evidence of a claim that the patient is receiving concurrent therapy for Parkinson s disease (e.g., levodopa, dopamine agonist, or monoamine oxidase B inhibitor) within the past 30 days Prescriber is a neurologist or the prescriber has consulted with a neurologist Approval will be for 12 months Updated 03/2018 IDEAL

34 Prior Authorization Group Arcalyst PA ARCALYST All FDA-approved indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent AND An active or chronic infection (e.g. tuberculosis, HIV, hepatitis B/C) Criteria for approval require BOTH of the following: 1. Patient has been diagnosed with Cryopyrin-Associated Periodic Syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS) or Muckle-Wells Syndrome (MWS) AND 2. ONE of the following: A. Patient is NOT currently being treated with another biologic agent OR B. Patient is currently being treated with another biologic agent and the agent will be discontinued prior to initiating the requested agent Patient is at least 12 years of age Approval will be for 12 months Updated 03/2018 IDEAL

35 Prior Authorization Group Armodafinil PA armodafinil tablet All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for approval require BOTH of the following: 1. ONE of the following: A. Patient has an FDA labeled indication for the requested agent OR B. Patient has an indication that is supported in CMS approved compendia for the requested agent AND 2. ONE of the following: A. Patient is receiving only one of the listed agents armodafinil OR modafinil within the past 90 days OR B. Patient has been treated modafinil within the past 90 days and will discontinue prior to starting the requested agent Patient is 17 years of age or over Approval will be for 12 months Updated 03/2018 IDEAL

36 Prior Authorization Group Atopic Dermatitis PA - Elidel ELIDEL All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for approval require ONE of the following: A. Patient has a diagnosis of atopic dermatitis or vulvar lichen sclerosus AND ONE of the following: i. Patient has had a trial and failure of a topical corticosteroid or topical corticosteroid combination preparation (e.g. clobetasol, hydrocortisone, triamcinolone) OR ii. Patient has a documented intolerance, FDA labeled contraindication or hypersensitivity to a topical corticosteroid or topical corticosteroid combination preparation OR B. Patient has a diagnosis of facial seborrhoeic dermatitis associated with HIV infection AND BOTH of the following: i. Patient is currently on an antiretroviral treatment regimen AND ii. ONE of the following: 1) Patient has had a trial and failure of a topical corticosteroid or topical antifungal treatment (e.g. hydrocortisone, triamcinolone, ketoconazole, nystatin-triamcinolone) OR 2) Patient has a documented intolerance, FDA labeled contraindication or hypersensitivity to a topical corticosteroid or topical antifungal treatment OR C. Patient has an indication that is supported in CMS approved compendia for the requested agent Approval will be for 12 months Updated 03/2018 IDEAL

37 Prior Authorization Group Atopic Dermatitis PA - Tacrolimus tacrolimus ointment All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for approval require ONE of the following: A. Patient has a diagnosis of facial or flexural psoriasis OR B. Patient has a diagnosis of atopic dermatitis AND ONE of the following: i. Patient has had a trial and failure with a topical corticosteroid or topical corticosteroid combination preparation (e.g. clobetasol, hydrocortisone, triamcinolone) OR ii. Patient has a documented intolerance, FDA labeled contraindication or hypersensitivity to a topical corticosteroid or topical corticosteroid combination preparation OR C. Patient has an indication that is supported in CMS approved compendia for the requested agent Approval will be for 12 months Updated 03/2018 IDEAL

38 Prior Authorization Group Benlysta PA BENLYSTA All FDA-approved indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for initial approval require ALL of the following: 1. Patient has a diagnosis of active systemic lupus erythematosus (SLE) disease AND 2. Patient has a history of positive autoantibody test results [positive antinuclear antibody (ANA 1:80 or greater) and/or anti-dsdna (30 IU/mL or greater)] AND 3. Patient has a history of 3 other SLE diagnostic criteria (i.e. malar rash, discoid rash, photosensitivity, oral ulcers, nonerosive arthritis, pleuritis/pericarditis, renal disorder [persistent proteinuria greater than 0.5 grams/day or cellular casts], hematologic disorder [hemolytic anemia (with reticulocytosis), leukopenia, lyphopenia, or thrombocytopenia], and/or immunologic disorder [positive finding of antiphospholipid antibodies or anti-sm antibodies]) AND 4. ONE of the following: A. There is evidence of a claim that the patient is currently on a standard of care SLE treatment regimen within the past 90 days comprised of at least ONE of the following: corticosteroids (e.g. methylprednisolone, prednisone), antimalarials (e.g. hydroxychloroquine, chloroquine), prescription nonsteroidal antiinflammatory drugs (NSAIDS) (e.g. ibuprofen, naproxen), and/or immunosuppressives (e.g. azathioprine, methotrexate, cyclosporine, or oral cyclophosphamide) OR B. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to any standard of care drug classes listed above AND 5. ONE of the following: A. Patient has NOT been treated with intravenous (IV) cyclophosphamide in the past 30 days OR B. Patient has been treated with IV cyclophosphamide in the past 30 days AND will discontinue prior to starting the requested agent AND 6. ONE of the following: A. Patient has NOT been treated with another biologic agent in the past 30 days OR B. Patient has been treated with another biologic agent in the past 30 days AND will discontinue prior to starting the requested agent Updated 03/2018 IDEAL

39 Approval will be for 12 months Criteria for renewal approval require ALL of the following: 1. Patient has been previously approved for the requested agent through the plan s PA criteria AND 2. Patient has diagnosis of active systemic lupus erythematosus (SLE) disease AND 3. ONE of the following: A. There is evidence of a claim that the patient is currently on a standard of care SLE treatment regimen within the past 90 days comprised of at least ONE of the following: corticosteroids (e.g. methylprednisolone, prednisone), antimalarials (e.g. hydroxychloroquine, chloroquine), prescription nonsteroidal antiinflammatory drugs (NSAIDS) (e.g. ibuprofen, naproxen), and/or immunosuppressives (e.g. azathioprine, methotrexate, cyclosporine, or oral cyclophosphamide) OR B. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to any standard of care drug classes listed above AND 4. Patient has had a decrease in symptoms or stabilization in at least ONE SLE diagnostic criteria (i.e. malar rash, discoid rash, photosensitivity, oral ulcers, nonerosive arthritis, pleuritis/pericarditis, renal disorder [persistent proteinuria greater than 0.5 grams/day or cellular casts], hematologic disorder [hemolytic anemia (with reticulocytosis), leukopenia, lymphopenia, or thrombocytopenia], and/or immunologic disorder [positive finding of antiphopholipid antibodies or anti-sm antibodies]) AND 5. ONE of the following: A. Patient has NOT been treated with intravenous (IV) cyclophosphamide in the past 30 days OR B. Patient has been treated with IV cyclophosphamide in the past 30 days AND will discontinue prior to starting the requested agent AND 6. ONE of the following: A. Patient has NOT been treated with another biologic agent in the past 30 days OR B. Patient has been treated with another biologic agent in the past 30 days AND will discontinue prior to starting the requested agent Updated 03/2018 IDEAL

40 Prior Authorization Group Benzodiazepines PA - Clonazepam clonazepam ODT clonazepam tablet All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Program applies to new starts only. Criteria for approval require ONE of the following: 1. BOTH of the following: A. ONE of the following: i. There is evidence of a claim that the patient is currently being treated with the requested agent within the past 180 days OR ii. Prescriber states the patient is currently using the requested agent AND B. Patient has an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested agent OR 2. BOTH of the following: A. Patient has ONE of the following diagnoses: i. Seizure disorder OR ii. Panic disorder AND ONE of the following: a. Patient s medication history includes use of a formulary selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) OR b. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to formulary SSRIs or SNRIs OR iii. Patient has an indication that is supported in CMS approved compendia for the requested agent AND B. Patient does NOT have any FDA labeled contraindication(s) to the requested agent Updated 03/2018 IDEAL

41 Approval will be for 12 months Updated 03/2018 IDEAL

42 Prior Authorization Group Benzodiazepines PA - Clorazepate clorazepate tablet All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Program applies to new starts only. Criteria for approval require ONE of the following: 1. BOTH of the following: A. ONE of the following: i. There is evidence of a claim that the patient is currently being treated with the requested agent within the past 180 days OR ii. Prescriber states the patient is currently using the requested agent AND B. Patient has an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested agent OR 2. BOTH of the following: A. Patient has ONE of the following diagnoses: i. Seizure disorder OR ii. Anxiety disorder AND ONE of the following: a. Patient s medication history includes use of a formulary selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) OR b. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to formulary SSRIs or SNRIs OR iii. Alcohol withdrawal OR iv. Patient has an indication that is supported in CMS approved compendia for the requested agent AND B. Patient does NOT have any FDA labeled contraindication(s) to the requested agent Updated 03/2018 IDEAL

43 Approval will be for 12 months Updated 03/2018 IDEAL

44 Prior Authorization Group Benzodiazepines PA - Diazepam DIAZEPAM 1 mg/ml oral solution diazepam tablet diazepam intensol concentrate All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Program applies to new starts only. Criteria for approval require ONE of the following: 1. BOTH of the following: A. ONE of the following: i. There is evidence of a claim that the patient is currently being treated with the requested agent within the past 180 days OR ii. Prescriber states the patient is currently using the requested agent AND B. Patient has an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested agent OR 2. BOTH of the following: A. Patient has ONE of the following diagnoses: i. Seizure disorder OR ii. Anxiety disorder AND ONE of the following: a. Patient s medication history includes use of a formulary selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) OR b. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to formulary SSRIs or SNRIs OR iii. Skeletal muscle spasms OR iv. Alcohol withdrawal OR v. Patient has an indication that is supported in CMS approved compendia for the requested agent AND B. Patient does NOT have any FDA labeled contraindication(s) to the requested agent Updated 03/2018 IDEAL

45 Approval will be for 12 months Updated 03/2018 IDEAL

46 Prior Authorization Group Benzodiazepines PA - Lorazepam lorazepam tablet All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Program applies to new starts only. Criteria for approval require ONE of the following: 1. BOTH of the following: A. ONE of the following: i. There is evidence of a claim that the patient is currently being treated with the requested agent within the past 180 days OR ii. Prescriber states the patient is currently using the requested agent AND B. Patient has an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested agent OR 2. BOTH of the following: A. Patient has ONE of the following diagnoses: i. Anxiety disorder AND ONE of the following: a. Patient s medication history includes use of a formulary selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) OR b. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to formulary SSRIs or SNRIs OR ii. Patient has an indication that is supported in CMS approved compendia for the requested agent AND B. Patient does NOT have any FDA labeled contraindication(s) to the requested agent Approval will be for 12 months Updated 03/2018 IDEAL

47 Updated 03/2018 IDEAL

48 Prior Authorization Group Benzodiazepines PA - Onfi ONFI All FDA-approved indications not otherwise excluded from Part D. All medically accepted indications not otherwise excluded from Part D. Program applies to new starts only. Criteria for approval require ONE of the following: 1. BOTH of the following: A. ONE of the following: i. There is evidence of a claim that the patient is currently being treated with the requested agent within the past 180 days OR ii. Prescriber states the patient is currently using the requested agent AND B. Patient has an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested agent OR 2. BOTH of the following: A. Patient has ONE of the following diagnoses: i. Seizure disorder OR ii. Patient has an indication that is supported in CMS approved compendia for the requested agent AND B. Patient does NOT have any FDA labeled contraindication(s) to the requested agent Approval will be for 12 months Updated 03/2018 IDEAL

49 Prior Authorization Group Biologic Immunomodulators PA - Cosentyx COSENTYX COSENTYX SENSOREADY PEN All FDA-approved indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for initial approval require ALL of the following: 1. Patient has an FDA labeled indication for the requested agent AND 2. ONE of the following: A. There is evidence of a claim that the patient is currently being treated with the requested agent within the past 90 days OR B. Prescriber states the patient is currently using the requested agent AND is at risk if therapy is changed OR C. Patient s medication history indicates use of another biologic immunomodulator agent for the same FDA labeled indication OR D. Patient s diagnosis does NOT require a conventional agent prerequisite OR E. Patient's medication history indicates use of ONE formulary conventional agent prerequisite for the requested indication OR F. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to at least ONE formulary conventional agent for the requested indication AND 3. Patient has been tested for latent TB AND if positive the patient has begun therapy for latent TB AND 4. Patient is NOT currently being treated with another biologic immunomodulator Criteria for renewal approval require ALL of the following: 1. Patient has been previously approved for the requested agent through the plan's PA criteria AND 2. Patient has an FDA labeled indication for the requested agent AND 3. Patient has shown clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency) AND 4. Patient is NOT currently being treated with another biologic immunomodulator Updated 03/2018 IDEAL

50 Approval will be for 12 months Formulary conventional agent required for diagnoses of psoriatic arthritis or psoriasis Diagnosis of ankylosing spondylitis does NOT require formulary conventional therapy Formulary conventional agents for psoriatic arthritis include methotrexate, hydroxychloroquine, sulfasalazine, minocycline, or leflunomide Formulary conventional topical or systemic antipsoriatic agents include topical corticosteroids, tazarotene, cyclosporine, calcipotriene, methotrexate, or acitretin Formulary biologic immunomodulator agents for psoriatic arthritis are Enbrel, Humira, Remicade, and Stelara, for psoriasis are Enbrel, Humira, Remicade, and Stelara, and for ankylosing spondylitis are Enbrel, Humira, and Remicade. Updated 03/2018 IDEAL

51 Prior Authorization Group Biologic Immunomodulators PA - Enbrel ENBREL ENBREL MINI ENBREL SURECLICK All FDA-approved indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for initial approval require ALL of the following: 1. Patient has an FDA labeled indication for the requested agent AND 2. ONE of the following: A. There is evidence of a claim that the patient is currently being treated with the requested agent within the past 90 days OR B. Prescriber states the patient is currently using the requested agent AND is at risk if therapy is changed OR C. Patient s medication history indicates use of another biologic immunomodulator agent for the same FDA labeled indication OR D. Patient s diagnosis does NOT require a conventional agent prerequisite OR E. Patient's medication history indicates use of ONE formulary conventional agent prerequisite for the requested indication OR F. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to at least ONE formulary conventional agent for the requested indication AND 3. Patient has been tested for latent TB AND if positive the patient has begun therapy for latent TB AND 4. Patient is NOT currently being treated with another biologic immunomodulator Criteria for renewal approval require ALL of the following: 1. Patient has been previously approved for the requested agent through the plan's PA criteria AND 2. Patient has an FDA labeled indication for the requested agent AND 3. Patient has shown clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency) AND 4. Patient is NOT currently being treated with another biologic immunomodulator Updated 03/2018 IDEAL

52 Approval will be for 12 months Formulary conventional agent required for diagnoses of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, or psoriasis Diagnosis of ankylosing spondylitis does NOT require formulary conventional therapy Formulary conventional agents for rheumatoid arthritis, juvenile idiopathic arthritis, or psoriatic arthritis include methotrexate, hydroxychloroquine, sulfasalazine, minocycline, or leflunomide Formulary conventional topical or systemic antipsoriatic agents include topical corticosteroids, tazarotene, cyclosporine, calcipotriene, methotrexate, or acitretin Formulary biologic immunomodulator agents for rheumatoid arthritis are Humira, Kineret, Orencia, Remicade, and Rituxan, for juvenile idiopathic arthritis are Humira and Orencia, for psoriatic arthritis are Cosentyx, Humira, Remicade, and Stelara, for psoriasis are Cosentyx, Humira, Remicade, and Stelara, and for ankylosing spondylitis are Cosentyx, Humira, and Remicade. Updated 03/2018 IDEAL

53 Prior Authorization Group Biologic Immunomodulators PA - Humira HUMIRA HUMIRA PEDIATRIC CROHNS DISEASE STARTER PACK HUMIRA PEN HUMIRA PEN-CROHNS DISEASE STARTER HUMIRA PEN-PSORIASIS STARTER All FDA-approved indications not otherwise excluded from Part D. FDA labeled contraindication(s) to the requested agent Criteria for initial approval require ALL of the following: 1. Patient has an FDA labeled indication for the requested agent AND 2. ONE of the following: A. There is evidence of a claim that the patient is currently being treated with the requested agent within the past 90 days OR B. Prescriber states the patient is currently using the requested agent AND is at risk if therapy is changed OR C. Patient s medication history indicates use of another biologic immunomodulator agent for the same FDA labeled indication OR D. Patient s diagnosis does NOT require a conventional agent prerequisite OR E. Patient's medication history indicates use of ONE formulary conventional agent prerequisite for the requested indication OR F. Patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to at least ONE formulary conventional agent for the requested indication AND 3. Patient has been tested for latent TB AND if positive the patient has begun therapy for latent TB AND 4. Patient is NOT currently being treated with another biologic immunomodulator Criteria for renewal approval require ALL of the following: 1. Patient has been previously approved for the requested agent through the plan's PA criteria AND 2. Patient has an FDA labeled indication for the requested agent AND 3. Patient has shown clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency) AND 4. Patient is NOT currently being treated with another biologic immunomodulator Updated 03/2018 IDEAL